ImpediMed Limited

Medical device manufacturer in Lindfield, AU.

17510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional 08/17/2026SE
K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)OBH · Traditional 01/28/2026SE
K232089SOZO ProDSB · Traditional 10/17/2023SE
K230531SOZO ProQJB · Special 05/04/2023SE
K230530SOZO ProOBH · Special 05/04/2023SE
K203473SozoDSB · Traditional 04/19/2021SE
K193410SOZO Body Fluid AnalyzerDSB · Traditional 10/02/2020SE
K190529SozoQJB · Traditional 11/25/2019SE
K180126SozoOBH · Traditional 04/16/2018SE
K172507SozoDSB · Traditional 12/22/2017SE
K172122SozoOBH · Special 08/11/2017SE
K130338Impedimed - Bis Extra Cellular Fluid AnalysisOBH · Traditional 05/31/2013SE
K100811Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400OBH · Traditional 11/04/2011SE
K080825Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400OBH · Traditional 10/03/2008SESK
K050415Impedimed-Extracellular Fluid AnalysisOBH · Traditional 03/30/2007SESK
K052319Impedimed - Body Composition Analyzer, Model Imp SFB7MNW · Traditional 04/04/2006SE
K050395Impedimed - Body Composition AnalysisMNW · Traditional 07/13/2005SE

Recalls

RecallProductInitiated
Z-0155-2024 Class IISOZO Bilateral Arm L-Dex SoftwareBilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs… 08/17/2023Open, Classified